Phase II Study of Ofatumumab in Elderly Patients With Chronic Lymphocytic Leukemia (CLL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborators:
National Comprehensive Cancer Network
GlaxoSmithKline
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01444716
First received: September 28, 2011
Last updated: June 13, 2014
Last verified: June 2014
  Purpose

The goal of this clinical research study is to learn if ofatumumab can help to control CLL. The safety of this drug will also be studied.

Ofatumumab is designed to bind to the surface of the leukemia cells . This may cause the leukemia cells to die.


Condition Intervention Phase
Advanced Cancers
Leukemia
Drug: Ofatumumab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Ofatumumab as Front-line Treatment in Elderly, Unfit Patients With Chronic Lymphocytic Leukemia (CLL)

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Overall Response Rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Number of participants with Overall Response (OR) which equals Complete and Partial Responses (CR+PR) divided by total number of participants. Response assessed after month 3, month 6 and every 6 months thereafter using the 2008 National Cancer Institute (NCI) Working Group criteria for response.


Estimated Enrollment: 34
Study Start Date: December 2011
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ofatumumab
Four weekly intravenous infusions at 300 mg during week 1, then 2,000 mg weeks 2, 3 and 4, then monthly during months 2-12.
Drug: Ofatumumab
Starting dose: 300 mg by vein during week 1, then 2000 mg in weeks 2, 3 and 4, then monthly during months 2-12.
Other Name: Arzerra

Detailed Description:

Study Drug Administration:

If you are found to be eligible to take part in this study, you will receive ofatumumab by vein every week for 4 weeks. After that, you will receive it every month. Each infusion will last about 4 hours.

Before you receive ofatumumab, you will be given drugs to help reduce the risk of side effects.

  • You will take Tylenol (acetaminophen) by mouth.
  • You will receive diphenhydramine by vein over about 5 minutes.
  • You will receive a steroid by vein over about 5 minutes.
  • You will take allopurinol by mouth during the first 14 days of treatment.

Study Visits:

Every other week, blood (about 1 teaspoon) will be drawn for routine tests.

Every month, you will have a physical exam. If your doctor thinks it is needed, you will also have a bone marrow biopsy to check the status of the disease.

After Month 6 and every 6 months after that, you will have a bone marrow biopsy and aspiration to check the status of the disease.

Length of Treatment:

You may continue receive the study drug for up to 12 months. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

This is an investigational study. Ofatumumab is FDA approved for the treatment of chronic lymphocytic leukemia that has relapsed. Its use in this study for initial treatment of CLL is investigational.

Up to 34 patients will take part in this study. All will be enrolled at MD Anderson.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with chronic lymphocytic leukemia requiring treatment age >65 at the time of signing informed consent.
  2. The Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance status of 2-3.or patients with chronic lymphocytic leukemia requiring treatment age >65 years at the time of signing informed consent and ECOG/WHO performance status of 0-1 and a CIRS or Charlson co-morbidity score of 2 or higher.
  3. Adequate renal and hepatic function (creatinine <2mg/dL and eGFR more than 30cc/minute, bilirubin <2mg/dL). Patients with renal or liver dysfunction due to organ infiltration by lymphocytes may be eligible after discussion with the study chairman. Patients with Gilbert's syndrome are eligible.

Exclusion Criteria:

  1. Patients with documented prolymphocytic leukemia (prolymphocytes more than 55% in the blood).
  2. Known positivity for HIV.
  3. Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HGsAg but HBcAb positive (regardless of HBsAb status), a HB DNA test will be performed and if positive the subject will be excluded.
  4. Prior treatment for chronic lymphocytic leukemia.
  5. Concurrent chemotherapy, radiotherapy, or immunotherapy, including other monoclonal antibodies. Localized radiotherapy to an area not compromising bone marrow function does not apply. Patients with malignancies with indolent behavior such as prostate cancer treated with radiation or surgery can be enrolled in the study as long as they have a reasonable expectation to have been cured with the treatment modality received.
  6. Any serious medical condition, laboratory abnormality, or psychiatric illness that places the subject at unacceptable risk if he/she were to participate in the study.
  7. Any known hypersensitivity to ofatumumab or its components.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01444716

Contacts
Contact: Alessandra Ferrajoli, MD, BS 713-792-2063

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Comprehensive Cancer Network
GlaxoSmithKline
Investigators
Principal Investigator: Alessandra Ferrajoli, MD,BS UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01444716     History of Changes
Other Study ID Numbers: 2011-0520, 15857, NCCN-006, NCI-2013-00726
Study First Received: September 28, 2011
Last Updated: June 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Advanced Cancers
Leukemia
Chronic Lymphocytic Leukemia
CLL
Elderly
Ofatumumab
Arzerra

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms
Neoplasms by Histologic Type
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on July 28, 2014